Sr. Director, Quality

KBI Biopharma; Durham (NC); On-site; USD 205,000 - 283,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC, seeks a Senior Director of Quality, Quality Site Head to lead QA and QC teams across microbial and mammalian production.

You will own raw material release, QA review of QC data, and compliance with cGMPs while partnering with global Quality and client teams. The role demands extensive quality management, regulatory inspections experience, and strategic leadership to drive continuous improvement and ensure site readiness for audits and manufacturing.

Qualifications

• Bachelor of Science degree in a scientific discipline with extensive quality management experience.
• Advanced degrees (Master's or PhD) are considered with commensurate quality experience.
• Minimum 15 years in regulated pharmaceutical industry with cGMP knowledge and biotech regulations.

Responsibilities

• Oversee and implement quality systems, standards, and procedures for inspecting, testing, and evaluating manufactured product.
• Lead, mentor, and develop departmental associates and manage performance to meet objectives.
• Be a key contributor to long term strategic planning and senior leadership decisions.
• Collaborate with internal and client teams to define Quality strategy and solve problems.

Skills

Quality leadership

Regulatory inspections

Quality systems

Risk management

Cross-functional leadership

Education

Bachelor of Science in a scientific discipline

Master's degree

PhD

Job description

Job Summary

Senior Director of Quality, Quality Site Head at a contract manufacturer of microbial fermentation and/or mammalian cell culture protein therapeutics. Lead a Quality Assurance and Quality Control team which includes both QC Analytical and QC Microbiology. The individual in this role is recognized as a subject matter expert with regard to Quality Assurance and Quality Control.

Quality Assurance

The Senior Director of Quality, Quality Site Head is accountable for raw material release, Quality on the floor, disposition of drug substance, QA review of quality control data, root cause analysis, risk management, deviation, Change Control and CAPA management, document/records management, quality metrics reporting, data integrity, training management, QA review of method qualification/validation, process qualification/validation, and equipment/utilities/ facilities qualification and continuous improvement. Partner with Global Quality in ensuring internal audits, client audits, supplier quality management, managing regulatory inspections, and quality systems are implemented effectively, efficiently, and compliantly at the site.

Quality Control

The Senior Director of Quality, Quality Site Head is accountable for QC Analytical and QC Microbiology. He/she is responsible for oversight of QC Analytical testing. He/she is responsible for oversight of QC Microbiology tasks including Bioburden, Endotoxin, TOC Conductivity, Water collection Osmolality, EM collection and testing, Organism/Media QC, EM Trending, Sample Accessioning, and Raw Material Program Management. Proven skills in the knowledge of 21CFR210, 211 is also required. This role is key in collaborating with site operations (Manufacturing, Facilities & Engineering, Supply Chain, EHS&S, and Operational Excellence) to ensure appropriate quality oversight. Partnership with the Operations and Site Head is crucial to ensure the site’s success. In consultation with the SVP of Quality and Regulatory, the Senior Director of Quality, Quality Site Head holds final accountability for and decision making on the matters relating to GMP compliance for the site.

Responsibilities:

• Oversee and implement quality systems, standards, and procedures for inspecting, testing, and evaluating manufactured product. Ensure the site is inspection ready at all times. Collaborates with other Quality Site Heads on continuous improvement initiatives.
• Lead, assess, mentor, and develop departmental associates. Manage performance; ensure team meets expectations and meets objectives; guide the professional growth of team members by providing personal guidance and training relative to responsibilities.
• Key contributor to long term strategic planning and part of senior leadership team.
• Work with internal and client teams to establish Quality strategy, define roles, and problem solve.

Minimum Requirements:

Minimum requirement is a Bachelor of Science degree in a scientific discipline with 8 years of quality management experience plus at least 5 years’ experience serving in a relevant technical management capacity required. A Master’s degree with 6 years or a PhD with 4 years of quality experience would be considered. At least 15 years of regulated pharmaceutical industry experience. CMO experience preferred. Must have thorough knowledge of cGMPs and biotechnology-derived product regulations. Also requires a demonstrated track record in the following key areas:

• Regulatory Inspection management
• Strong orientation for Quality and Customer Service
• Strong collaboration and team building skills
• Support attainment of aggressive growth and profit objectives by ensuring adherence to Quality Systems as required by various regulatory bodies
• Demonstrated level of respect for individuals
• High level of integrity and personal responsibility
• Record of innovation
• Experience developing, implementing, and executing strategic plans and objectives for organizations and departments

Must have:

• Ability to read, analyze, and interpret the most complex documents.
• Ability to respond effectively to the most sensitive inquiries or complaints. Ability to write speeches and articles using original or innovative techniques or style.
• Ability to make effective and persuasive speeches and presentations on controversial or complex topics to senior management peer group, employee groups, customers, and/or the boards of directors.
• Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
• Ability to understand and interpret nonverbal symbolism (formulas, scientific equations, graphs, etc.,) in its most difficult phases.
• Ability to deal with a variety of abstract and concrete variables.
• Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
• Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
• Ability to sit or stand for long periods of time.
• Ability to use a computer, telephone, spreadsheets, PowerPoint, Outlook.

Range: $205,000.00 / yr - $283,00.00 / yr

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.